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Evaluation of Effects of CBD Products on Anxiety Among U.S. Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05108220
Recruitment Status : Completed
First Posted : November 4, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Radicle Science

Brief Summary:
The investigators will conduct a retrospective cohort analysis of a consumer trial conducted by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD) products. Participants were randomized to one of 9 groups: 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery, concentration of Tetrahydrocannabinol (THC), and dosage of CBD. Participants were asked to use the product once daily for 60 day and to complete health questionnaires at baseline, 30 days and 60 days.

Condition or disease Intervention/treatment
Anxiety Generalized Anxiety Disorder Dietary Supplement: Cannabidiol (CBD)- containing consumer products

Detailed Description:
Between October 1-7, 2020, women from across the US were recruited by Rae Wellness to participate in a 60-day in-home use test (IHUT) of various Cannabidiol (CBD) products. The inclusion criteria were: women; between the ages of 24-44; reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido). Individuals were excluded if they were pregnant or breastfeeding. 1,350 women were randomly selected to participate in the study. The participants were randomized to one of 9 groups in the IHUT (150 in each group): 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery (oil or capsule), concentration of Tetrahydrocannabinol (THC; less than 0.3% THC or 0% THC), and dosage of CBD (15, 20, 25 and 30 mg). Participants were asked to use the product once daily every day for 60 consecutive days, and to complete a health questionnaire online on 3 occasions: before initiating the product (baseline), 30 days after initiating the product, and 60 days after initiating the product. Those in the control group were also asked to complete the health questionnaire at each time point but did not receive nor consume any CBD product. The health questionnaire assessed anxiety, physical health, digestive health, sleep patterns, general wellness and sexual satisfaction using questions drawn from validated health indices.

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Study Type : Observational
Actual Enrollment : 1350 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Cohort Study to Evaluate the Effects of Cannabidiol (CBD)-Containing Test Products on Anxiety Among Women in the U.S.
Actual Study Start Date : October 15, 2020
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cannabidiol

Group/Cohort Intervention/treatment
R-101
CBD oil, 30 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-102
CBD oil, 20 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-103
CBD oil, 30 mg CBD per serving, <0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-104
CBD oil, 20 mg CBD per serving, <0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-105
CBD capsule, 15 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-106
CBD capsule, 25 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-107
CBD capsule, 15 mg CBD per serving, <0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-108
CBD capsule, 25 mg CBD per serving, <0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method
Dietary Supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.

Control
Waitlist control; no product



Primary Outcome Measures :
  1. Anxiety [ Time Frame: 60 days ]
    Anxiety score, according to the Generalized Anxiety Disorder (GAD)-7 scale. Scores range from 0 to 21, with higher scores representing more severe anxiety.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   24 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identified as female at enrollment
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
1350 women from across the United States
Criteria

Inclusion Criteria:

  • Self-identified female
  • Ages of 24 to 44 years
  • Reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido).

Exclusion Criteria:

-Pregnant or breastfeeding


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05108220


Locations
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United States, Minnesota
Rae Wellness PBC
Minneapolis, Minnesota, United States, 55402
Sponsors and Collaborators
Radicle Science
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Responsible Party: Radicle Science
ClinicalTrials.gov Identifier: NCT05108220    
Other Study ID Numbers: Pro00054510
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radicle Science:
Cannabidiol
Tetrahydrocannabinol
Anxiety
Women
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Cannabidiol
Anticonvulsants